MedTrace Logo

Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea

NCT03045926 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-04-05

Study results available
· View outcomes & findings →

Summary

The main purpose of this study is to assess the concentration of elemental impurities in blood and urine after chronic administration of Smecta® in subjects with chronic functional diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel microbiote composition will be investigated.

Conditions

  • Chronic Functional Diarrhea of Unknown Origin

Interventions

DRUG

Diosmectite (Smecta®)

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-05-09
Completion
2017-05-09

Countries

  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03045926 on ClinicalTrials.gov